Health TrialsbyHealthPanel

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ConditionCoronary Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorRobocath

About this trial

The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age ≥ 18 years;

2.Subjects with coronary artery disease with clinical indication for PCI;

3.Subject deemed appropriate for robotic-assisted PCI; and

4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Disqualifiers

1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or

2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.

3.STEMI

4.Cardiogenic shock

Trial population

Subjects with coronary artery disease and a clinical indication for PCI

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Robotic-assisted PCI

    Device

    Robotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Study population1 intervention

Trial outcomes

Primary outcomes

1

Clinical success

Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse cardiac events (MACE).

Time frame
From Day 0 to Day 3
2

Technical success

Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion

Time frame
During procedure

Secondary outcomes

1

Radiation exposure for the patient

Dose (DSP and Air Kerma) measured by the imaging system during the procedure.

Time frame
During procedure
2

Overall Procedure Time

Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

Time frame
During procedure
3

Overall contrast volume

Total volume of contrast (mL) used during the procedure.

Time frame
During procedure
4

Radiation exposure for the operator

Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure.

Time frame
During procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robocath

Lead sponsor

European Cardiovascular Research Center

Collaborator

Source ClinicalTrials.gov
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